Resveratrol and the Metabolic Syndrome
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Purpose
Metabolic syndrome is a serious health condition that affects about 35 percent of adults and places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity, being overweight, physical inactivity and genetic factors. In recent decades, the prevalence has increased dramatically in the United States. Lifestyle interventions including dietary modification, physical activity and weight loss form the basis of treatment for these patients. However, research has shown that even when people are able to incorporate these changes, they often revert back to their usual lifestyle resulting in weight gain and continued risk for diabetes and heart disease.
Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has been found to reverse some of the features of the metabolic syndrome (insulin resistance, high triglycerides, high blood pressure) in rodents. These improvements occurred without weight loss, and were proven to be a direct result of resveratrol ingestion. Other studies reveal improvement in cardiovascular health, tumor suppression, and longevity. However, there are few studies investigating these beneficial effects in humans. Investigators propose to prove that resveratrol, administered to subjects with the metabolic syndrome, under controlled conditions of weight stability, common diet, and strict compliance with the study drug, will improve the symptoms of the metabolic syndrome, thereby decreasing the chance of developing diabetes or heart disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Insulin Resistance Metabolic Syndrome |
Dietary Supplement: Resveratrol Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effects of Trans-Resveratrol (RSV) on Insulin Resistance, Inflammation, and the Metabolic Syndrome: A Placebo Controlled, Double-Blind Study. |
- Reduction in Insulin resistance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Investigators anticipate resveratrol will have positive effect (ie reduction) on Insulin resistance as determined by Euglycemic hyperinsulinemic clamp
- Reduction in serum cytokines/chemokines [ Time Frame: collected within 4 weeks ] [ Designated as safety issue: No ]Investigators anticipate resveratrol will have positive effect (ie reduction) on Serum cytokines/chemokines: IL6, IL10, TNFalpha, hsCRP, leukocytes, PAI-1, fibrinogen, adiponectin, MCP-1,GLP-1, leptin, insulin, serum endotoxins
- Reduction in blood pressure measurements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]24 hour systolic blood pressure measurements
- Reduction lipid values [ Time Frame: End of study ] [ Designated as safety issue: No ]Lipid values to be reviewed: cholesterol, LDL, HDL, TG
- Reduction in crown like structures and adipose tissue mass [ Time Frame: End of study ] [ Designated as safety issue: No ]Crown like structures in adipose tissue, and adipose tissue mass
- Changes in HOMA-IR [ Time Frame: End of study ] [ Designated as safety issue: No ]Changes in 2 hr oral glucose tolerance test HOMA-IR
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo for 30 days
|
Dietary Supplement: Placebo
Placebo manufactures to mimic resveratrol tablet
|
|
Active Comparator: Resveratrol
1000 mg PO BID for 30 days
|
Dietary Supplement: Resveratrol
Subjects receive either Resveratrol or placebo PO BID for 30 days
|
Detailed Description:
The metabolic syndrome is a serious health condition that affects about 35 percent of adults and places them at higher risk of cardiovascular disease, diabetes, stroke and diseases related to fatty buildups in artery walls. The underlying causes of metabolic syndrome are obesity, being overweight, physical inactivity and genetic factors. In recent decades, the prevalence has increased dramatically in the United States. Lifestyle interventions including dietary modification, physical activity and weight loss form the basis of treatment for these patients. However, research has shown that even when people are able to incorporate these changes, they often revert back to their usual lifestyle resulting in weight gain and continued risk for diabetes and heart disease.
Resveratrol, a natural plant derived compound found in grapes, peanuts and red wine, has been found to reverse some of the features of the metabolic syndrome (insulin resistance, high triglycerides, high blood pressure) in rodents. These improvements occurred without weight loss, and were proven to be a direct result of resveratrol ingestion. Other studies reveal improvement in cardiovascular health, tumor suppression, and longevity. However, there are few studies investigating these beneficial effects in humans. In a systematic review of resveratrol research, the authors conclude that "in contrast to the lacking data of resveratrol in humans, the animal data are promising and indicate the need for further human clinical trials." Of the small clinical studies that have been done, the results are encouraging. Improvement in triglycerides, blood pressure and insulin resistance were noted. Resveratrol was well tolerated without serious side effects. These studies, however, did not recruit subjects with the metabolic syndrome, nor were they tightly controlled.
The investigators propose to prove that resveratrol, administered to subjects with the metabolic syndrome, under controlled conditions of weight stability, common diet, and strict compliance with the study drug, will improve the symptoms of the metabolic syndrome, thereby decreasing the chance of developing diabetes or heart disease.
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 30 - 60 year old men
- Willingness to be randomized to resveratrol or placebo.
- BMI 30-40
Evidence of insulin resistance with one of the following:
2 hr oral glucose tolerance result =/>120mg/dl at 2hrs acanthosis nigricans, or HgA1C 5.7 - 7.9% AND at least 2 of the following: waist circumference > 102 cm triglycerides > 150 but < 500 mg/dL HDL < 40 mg/dL Pre- hypertension or hypertension: BP>120/80 mmHg but <150/90 mmHg
- Willingness to consume only study food and drink during the in-pt phases
- Willingness to avoid the use of over-the-counter medications, herbs, or supplements within the last 30 days.
- Willingness to avoid NSAIDS (advil, aleve, motrin, etc.) and aspirin for the entire study
- Willingness to avoid ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, and red wine throughout the entire study, including run-in period.
- Willingness to maintain weight for the duration of the study.
- Willingness not to start an exercise regime during study participation
Exclusion Criteria:
- Tobacco smoker any time within the last 3 months
- Bleeding disorder by history or by Bleeding Questionnaire results
- History, physical or EKG findings suggestive of CV disease including angina, MI, hx of med/surg tx of atherosclerotic heart disease, or congestive heart disease
- BP > 145/90 after 10 minutes of rest on 2 or more screening visits
- Fasting glucose > 165 mg/dL at screening
- HbA1C > 8.0 at screening
- Current use of oral hypoglycemic agents
- Chronic glucocorticosteroid use or use of oral glucocorticosteroids for 5 days within the last year (inhaled glucocorticosteroid use may be acceptable; this will be determined by the PI)
- Current use of over the counter or prescription weight loss medication
- Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin).
- Hyperthyroidism or untreated hypothyroidism
- Obstructive sleep apnea, or significant symptoms suggestive of this condition.
- Current use of anticoagulants
- Known history of chronic hepatitis or liver enzymes (ALT or AST > 2.5 times the normal upper limit)
- Known HIV infection or confirmed positive test for HIV antibodies at screening
- Inflammatory bowel disease
- Active cancer (currently under treatment)
- Other medical condition that may cause significant weight loss or gain
- Chronic or acute renal disease
- Seizure disorder
- History of any psychiatric hospital admission within the last 2 years
- History of schizophrenia, psychosis, or bipolar disease
- History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, impact the subject's ability to successfully participate in the study.
- Alcohol or drug abuse within the last 2 years
- Any medications metabolized by cytochrome p450 3A4 (CYPA3A4) (see attachment of these medications as an appendix)
- Any autoimmune disease (ie rheumatoid arthritis, systemic lupus erythematosis, psoriasis)
- Physical condition requiring special diet (ie celiac disease)
Contacts and Locations| Contact: Caroline Melendez | 1-800-782-2737 | rucares@rockefeller.edu |
| United States, New York | |
| The Rockefeller University | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Lauren Corregano 800-782-2737 rucares@rockefeller.edu | |
| Principal Investigator: Jeanne Walker, MSN/NP-C | |
| Principal Investigator: | Jeanne Walker, MSN/NP-C | The Rockefeller University |
More Information
No publications provided
| Responsible Party: | Jeanne Walker, Senior Clinical Nurse Practitioner & Research Coordinator, Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT01714102 History of Changes |
| Other Study ID Numbers: | JWA-0786 |
| Study First Received: | October 16, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rockefeller University:
|
Obesity Insulin resistance Metabolic syndrome Pre-diabetes |
Additional relevant MeSH terms:
|
Insulin Resistance Obesity Metabolic Syndrome X Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013